Phase II Study of Antineoplastons A10 and AS2-1 in Adult Patients With Primary Malignant Brain Tumors
- Provide antineoplastons A10 and AS2-1 as treatment for patients with incurable primary
malignant brain tumor that has progressed during or is recurrent or persistent after
prior standard therapy, including radiotherapy and/or chemotherapy.
- Describe the response to, tolerance to, and side effects of this regimen in these
OUTLINE: Patients receive gradually escalating doses of intravenous antineoplastons A10 and
AS2-1 6 times per day until the maximum tolerated dose is reached. Treatment continues for
at least 3 months in the absence of disease progression or unacceptable toxicity. Patients
achieving complete response (CR) continue treatment for an additional 8 months after
Patients are followed at least every 2 months for 1 year, every 3 months for the second
year, every 3-4 months for the third and fourth years, every 4-6 months for the fifth year,
and then annually thereafter.
PROJECTED ACCRUAL: Approximately 20-40 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Response rate based on tumor measurements taken at 12 weeks
Stanislaw R. Burzynski, MD, PhD
Burzynski Research Institute
|Burzynski Clinic||Houston, Texas 77055-6330|